FDA approves first once daily combination PAH treatment

The US Food and Drug Administration (FDA) has approved Opsynvi (macitentan and tadalafil), a single-tablet combination of an endothelin receptor antagonist (ERA), and a phosphodiesterase 5 (PDE5) inhibitor.

Developed by US healthcare giant Johnson & Johnson (NYSE: JNJ), Opsynvi is authorized for the chronic treatment of adults with pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group I) and WHO functional class (FC) II-III. This is the first and only approval by the FDA of a once daily combination for PAH.

Opsynvi may be used in patients with PAH who are treatment-naïve or who are already on an ERA, PDE5 inhibitor or both. Additionally, Opsynvi can be used in patients who are currently treated concomitantly with stable doses of macitentan 10 mg and tadalafil 40 mg (20 mg x 2) as separate tablets.